title: Weekly intravesical bacillus Calmette-Guerin (BCG) alternating with epirubicin in Ta and T1 urothelial bladder cancer: An approach to decrease BCG toxicity.
abstract: BACKGROUND
  Bacillus Calmette-Guerin (BCG) therapy is the standard treatment for nonmuscle-invasive bladder cancer (NMIBC). However, its toxicity is a major concern.
  
  
  OBJECTIVE
  If we reduce the number of BCG doses by half and replace the second half with epirubicin, we may have a lower toxicity while maintaining the same efficacy of BCG. To test this hypothesis, we conducted this study as an update of our previous report.
  
  
  METHODS
  The study included 607 patients with Ta and T1 NMIBC between January 1994 and December 2008.
  
  
  METHODS
  After transurethral resection of bladder tumor (TURBT), the patients received weekly doses of 120 mg BCG alternating with 50 mg epirubicin for six weeks (three weekly doses of each). Maintenance was given. Recurrence, progression rates, and toxicity were assessed. End points were progression, recurrence, and cancer-specific survival.
  
  
  RESULTS
  A total of 532 patients were eligible for evaluation (mean age: 58 years; median follow-up: 45 months). Of these, 291 (55%) were free, 157 (29.5%) showed recurrence, and 84 (15.8%) showed muscle-invasive progression. Toxicity developed in 221 patients. These were mild in the majority (167), whereas 10 developed hematuria, 30 severe cystitis, and five systemic complications. The rate of permanent therapy discontinuation was 3.8%.
  
  
  METHODS
  SPSS package version 16 and Kaplan-Meier curves were used to evaluate survival.
  
  
  CONCLUSIONS
  Reducing the frequency of BCG instillations by half and replacing the second half with epirubicin results in a similar efficacy and a lower toxicity compared with historical cases receiving BCG alone. However, further trials are required to support these results.
authors.affiliation: Department of Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
authors.forename: Bedeir
authors.initials: B
authors.lastname: Ali-El-Dein
authors.forename: Tamer S
authors.initials: TS
authors.lastname: Barakat
authors.forename: Adel
authors.initials: A
authors.lastname: Nabeeh
authors.forename: El-Housseiny I
authors.initials: el-HI
authors.lastname: Ibrahiem
keywords: Bacillus Calmette-Guerin; T1; Ta; epirubicin; nonmuscle-invasive bladder cancer; toxicity